PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Interventions
- Drug: PD-1 blocking antibodyDrug: GPRadiation: IMRT
- Registration Number
- NCT03907826
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 212
- Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
- Not suitable for surgery;
- Newly histologic diagnosis of NPC (WHO II/III);
- Clinical stage rII-IVa (AJCC/UICC 8th);
- ECOG 0-1 point;
- No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
- No contraindications to immunotherapy or radiotherapy;
- Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
- Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
- Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
- Take effective contraceptions during and two months after treatment;
- Patients must be informed of the investigational nature of this study and give written informed consent.
- Treated with anti-tumor Chinese medicine treatment;
- Have recurrence with local necrosis;
- Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
- Unexplained fever > 38.5 ℃, except for tumor fever;
- Treated with ≥ 5 days antibiotics one month before enrollment;
- Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E4copiers/ml) or hepatitis C virus (HCV) antibody positive; Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
- Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
- Have known allergy to large molecule protein products or any compound of study therapy;
- Pregnant or breastfeeding;
- Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
- Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
- Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PD-1 antibody plus chemoradiotherapy PD-1 blocking antibody Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles. PD-1 antibody plus chemoradiotherapy GP Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles. PD-1 antibody plus chemoradiotherapy IMRT Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles. Chemoradiotherapy GP Patients randomized to this arm will receive three cycles of GP chemotherapy, then receive IMRT alone. Chemoradiotherapy IMRT Patients randomized to this arm will receive three cycles of GP chemotherapy, then receive IMRT alone.
- Primary Outcome Measures
Name Time Method Overall survival 3 years From date of randomisation to death
- Secondary Outcome Measures
Name Time Method Progression free survival 3 years From date of randomisation to disease progression
Short-term effects through study completion, an average of 2 months Patient's objective response rate
Rate of patients with acute toxicities through study completion, an average of 2 months Evaluating with CTCAE v5.0
Quality of life: EuroQoL 5 dimension through whole study, an average of 3 years Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)
Trial Locations
- Locations (12)
Peking University Third Hospital
🇨🇳Beijing, China
Sichuan Cancer Hospital
🇨🇳Chengdu, China
Fujian Province Cancer Hospital
🇨🇳Fuzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, China
Guizhou Cancer Hospital
🇨🇳Guiyang, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, China
Xijing Hospital
🇨🇳Xi'an, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, China